Sher, Neal
`
`Case IPR2022-00142
`
`August 10, 2022
`
`1
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
` -------------------------
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
` -------------------------
`
` SLAYBACK PHARMA LLC
` Petitioner
` v.
` EYE THERAPIES, LLC
` Patent Owner
` -------------------------
` Case No. IPR2022-00142
` Patent No. 8,293,742
` -------------------------
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Eye Therapies Exhibit 2162, 1 of 60
`Slayback v. Eye Therapies - IPR2022-00142
`
`

`

`Sher, Neal
`
`Case IPR2022-00142
`
`2
` UNITED STATES PATENT AND TRADEMARK OFFICE
` -------------------------
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` -------------------------
`
` SLAYBACK PHARMA LLC
` Petitioner
` v.
` EYE THERAPIES, LLC
` Patent Owner
` -------------------------
` Case No. IPR2022-00146
` Patent No. 9,259,425
` -------------------------
`
` VIDEOTAPED DEPOSITION OF
` NEAL A. SHER, M.D., FACS
` Wednesday, August 10, 2022
` Chicago, Illinois
` 8:52 a.m. CST
`
`Reported by:
`Janice M. Kocek, CSR, CLR
`Job No. 52405
`
`3
`
` The videotaped deposition of
`NEAL A. SHER, M.D., FACS, called by the Patent
`Owner for examination, reported stenographically
`by Janice M. Kocek, License No. 084-002871,
`Certified Shorthand Reporter and Certified
`LiveNote Reporter, and Notary Public for the
`State of Illinois, held at 70 West Madison,
`Chicago, Illinois, commencing at the hour of 8:52
`a.m. CST, on the 10th of August, 2022.
`
` * * *
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`August 10, 2022
`2 (Pages 2 to 5)
`4
`
`A P P E A R A N C E S:
` ** ALL PARTIES APPEARING REMOTELY **
`
`ON BEHALF OF THE PETITIONER:
` GOODWIN PROCTER LLP
` The New York Times Building
` 620 Eighth Avenue
` New York, New York 10018
` 212.813.8800
` BY: LINNEA P. CIPRIANO, ESQ.
` lcipriano@goodwinlaw.com
`
` ON BEHALF OF THE PETITIONER:
` WENDELS MARX
` One Giralda Farms
` Madison, New Jersey 07940
` 973.966.3200
` BY: LOUIS H. WEINSTEIN, ESQ.
` lweinstein@windelsmarx.com
`
`5
`
`A P P E A R A N C E S:
`
`ON BEHALF OF THE PATENT OWNER:
` FINNEGAN, HENDERSON, FARABOW,
` GARRETT & DUNNER, LLP
` 901 New York Avenue, NW
` Washington, DC 20001-4413
` 202.408.4000
` BY: BRYAN C. DINER, ESQ.
` bryan.diner@finnegan.com
` CAITLIN E. O'CONNELL, ESQ.
` caitlin.o'connell@finnegan.com
` CHRISTINA JI-HYE YANG, ESQ. (remotely)
` christina.yang@finnegan.com
`
`ALSO PRESENT:
` BEN STANSON, videographer
`
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`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Eye Therapies Exhibit 2162, 2 of 60
`Slayback v. Eye Therapies - IPR2022-00142
`
`

`

`Sher, Neal
`
`Case IPR2022-00142
`
`6
`
` INDEX
`
`TESTIMONY OF NEAL A. SHER, M.D., FACS PAGE
` Examination by Mr. Diner 8, 136
` Examination by Ms. Cipriano 133
`
` DEPOSITION EXHIBITS
`NUMBER DESCRIPTION PAGE
`Exhibit 1 Declaration of 14
` Neal A. Sher, M.D., FACS
` Patent No. 8,293,742
`Exhibit 2 Declaration of 20
` Neal A. Sher, M.D., FACS
` Patent No. 9,259,425
`Exhibit 3 United States Patent 54
` 8,293,742 B2
`Exhibit 4 United States Patent 54
` 9,259,425 B2
`Exhibit 5 United States Patent 114
` 6,294,553 B1
`Exhibit 6 ARVO Investigative 124
` Ophthalmology & Visual Science
` Annual Meeting Abstract
` Issue, April 28 - May3, 1991,
` Sarasota, Florida
`
`7
`
` DEPOSITION EXHIBITS
`NUMBER DESCRIPTION PAGE
`Exhibit 7 United States Patent 127
` 6,242,442 B1
`Exhibit 8 Highlights of Prescribing 131
` Information - Simbrinza
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`August 10, 2022
`3 (Pages 6 to 9)
`8
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` THE VIDEOGRAPHER: This is Ben
` Stanson with Henderson Legal Services. I'm
` the operator of this camera. We are on the
` record on August 10th, 2022, and the time
` is 8:52 a.m. as indicated on the video
` screen. We are at HeplerBroom located at
` 70 West Madison Street in Chicago,
` Illinois.
` This is the videotaped
` deposition of Dr. Neal Sher that's being
` taken pursuant to Federal Rules of Civil
` Procedure on behalf of the patent holder.
` This case is captioned Slayback Pharma LLC
` versus Eye Therapies, LLC, Case Nos.
` IPR2022-00142 and IPR2022-00146.
` Will the attorneys please
` identify themselves for the record.
` MR. DINER: Bryan Diner. I'm joined
` by colleague, Caitlin O’Connell, with the
` Finnegan law firm. We represent the patent
` holder.
` MS. CIPRIANO: Linnea Cipriano of
` Goodwin representing the petitioner and the
` witness.
` MR. WEINSTEIN: Louis Weinstein of
`
`9
`
` Windels Marx representing the petitioner.
` THE VIDEOGRAPHER: Thank you.
` Our court reporter today is
` Janice Kocek also with Henderson Legal
` Services.
` Will you please swear in the
` witness and then counsel, you may proceed.
` (Witness sworn.)
` NEAL A. SHER, M.D., FACS,
`called as a witness herein, having been first
`duly sworn, was examined and testified as
`follows:
` EXAMINATION
`BY MR. DINER:
` Q. Good morning, Dr. Sher.
` A. Good morning.
` Q. How are you?
` A. Good, Mr. Diner.
` Q. Would you please state your name and
`address for the record?
` A. Neal Andrew Sher, 132 East Delaware
`Place, Chicago, 60611.
` Q. Have you been deposed before, Doctor?
` A. I have.
` Q. And how many times?
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Eye Therapies Exhibit 2162, 3 of 60
`Slayback v. Eye Therapies - IPR2022-00142
`
`

`

`Sher, Neal
`
`Case IPR2022-00142
`
`August 10, 2022
`4 (Pages 10 to 13)
`12
`
`10
`
` A. Probably in the range of about 20
`times.
` Q. And were those depositions in which
`you were deposed, were you deposed as an expert
`witness?
` A. One may have been a witness of fact
`in a patient-related injury, workmen's comp.
`But most of them -- all of them were expert.
` Q. Were any of them lawsuits dealing
`with the patent matters?
` A. Some.
` Q. Do you recall how many?
` A. I believe -- I can get you that
`number but I do not. Probably in the range of
`eight to ten but I haven't counted.
` Q. Was the most recent patent case in
`which you were an expert the Alcon v. Watson
`case?
` A. Yes.
` Q. And do you recall how many years ago
`that was?
` A. It was pre COVID but not -- maybe
`2019.
` Q. And that was within the last four
`years?
`
`11
`
` A. Yes.
` Q. Were there any other patent cases
`that you were an expert in within the last four
`years?
` A. No.
` Q. Generally in the patent cases in
`which you were an expert, what was the subject
`matter of your testimony?
` MS. CIPRIANO: Objection to form.
` THE WITNESS: I could speak to the
` Lupin case. It had to do with the generic
` drug regarding forms of olopatadine, an
` antihistamine drug.
`BY MR. DINER:
` Q. And when you said the Lupin case, do
`you mean the Alcon v. Watson v. Lupin case?
` A. Correct.
` Q. And were you testifying on behalf of
`Watson in Lupin?
` A. Yes.
` Q. And was your testimony directed to
`the validity of the patents in that lawsuit?
` A. Testimony related to the practice of
`the patents.
` Q. What do you mean by "the practice of
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`the patents"?
` A. I was asked questions regarding the
`clinical use of these drugs, among other things.
` Q. In that case, did you testify that
`the patents of -- in suit were invalid?
` A. I don't recall the details. I would
`have to review it. It had to do with the
`concentrations of the drug and whether -- and it
`had to do with validity of the patents. But I
`would need to review it. I haven't looked at
`that time in some years.
` Q. In the Alcon v. Watson case, did you
`testify on issues relating to claim
`construction?
` Do you know what I mean by claim
`construction?
` A. Yes.
` Q. Can you answer my question?
` A. The answer's no.
` Q. Okay. Great.
` Since you've been deposed before many
`times, you probably know the drill. But I'll
`just go through it quickly so that we're all on
`the same page if that's fine with you.
` As we have started, I'll ask the
`
`13
`
`questions. You'll answer them.
` If you need a break, please let me
`know. If there's a question pending, I just ask
`that you answer the question and then we can
`take a break; is that okay?
` A. Yes.
` Q. If for any reason you don't
`understand my question, you can ask and I'll be
`happy to clarify something that you don't
`understand or reask the question as you like; is
`that okay?
` A. Okay.
` Q. But if you answer my question, I will
`assume you understood what I was asking; is that
`fair?
` A. If I understand the question, yes.
` Q. Is there any reason why you cannot
`testify truthfully and accurately today?
` A. No.
` Q. And as the -- was read into the
`record earlier, the deposition today pertains to
`the two IPRs. I'll just read the numbers.
`IPR2022-00142 and IPR2022-00146.
` And do you understand that your
`testimony today at this deposition pertains to
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Eye Therapies Exhibit 2162, 4 of 60
`Slayback v. Eye Therapies - IPR2022-00142
`
`

`

`Sher, Neal
`
`Case IPR2022-00142
`
`August 10, 2022
`5 (Pages 14 to 17)
`16
`
`14
`
`the opinions that you offered in those two
`proceedings?
` A. Yes.
` Q. Okay.
` MR. DINER: So we'll be marking the
` first exhibit. This will be Sher Exhibit
` No. 1.
` MS. CIPRIANO: Thank you.
` MR. DINER: You're welcome.
` (Sher Deposition Exhibit 1 was
` marked for identification.)
`BY MR. DINER:
` Q. Dr. Sher, the court reporter has just
`handed you what has been marked as Sher
`Exhibit 1.
` Do you recognize this document as the
`declaration that you offered in IPR2022-00142?
` A. Yes.
` Q. And this pertains to -- you can read
`from the front of it -- to U.S. Patent
`8,293,742.
` Do you see that?
` A. Yes.
` Q. Can I refer to this as the '742
`declaration? Will that be a good easy shorthand
`
`15
`
`for you as well?
` A. Yes, please.
` Q. And Sher Exhibit 1 is the declaration
`that you submitted in connection with your
`opinions in the inter partes review related to
`the '742 patent, right?
` A. Yes, sir.
` Q. Just turn to page 66 of Sher
`Exhibit 1.
` Is that your signature on page 66
`dated November 4th, 2021?
` A. Yes.
` Q. And who prepared your '742
`declaration?
` A. I worked with Mr. Weinstein and it
`was an iterative process and it was prepared
`together.
` Q. Okay. Did you type this declaration?
` A. Not the final one, no.
` Q. Okay. Did you contribute some text
`that you composed yourself to this declaration?
` A. Yes.
` Q. Do you recall what sections of the
`declaration that you composed yourself that
`would have -- you would have contributed to this
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`declaration?
` A. There -- there were several -- a
`number of areas that I would go over and put in
`the sections, particularly on my background and
`such. But there were numerous areas that I
`prepared.
` Q. Do you remember those areas generally
`other than your background?
` A. Had to do with descriptions of some
`of the procedures and descriptions of some of
`the references in exhibits.
` Q. Okay. Do you recall how many hours,
`generally speaking, you spent preparing the '742
`declaration?
` A. I prepared both the '742 and the '425
`will be referred to. And I would say that I
`have to look at my spreadsheets and the bills
`but probably 30 to 40 hours for both.
` Q. So that's 30 to 40 hours total to
`prepare both the '742 and the '425 declarations?
` A. That sounds about right.
` Q. Okay. Does that include the time you
`spent reviewing the materials that you cite
`throughout your '742 and '425 declarations?
` A. I don't understand the question.
`
`17
`
` Q. The 30 to 40 hours total, does that
`also include the time you would have spent
`reviewing the materials that you cited in your
`declarations?
` A. Yes.
` Q. Okay. Are there any corrections you
`would like to make to your declaration today?
` A. Yes.
` Q. Which is?
` A. I noted recently in going over this,
`we referenced an article by -- actually one of
`my friends wrote it -- by Pasquali. It came
`from Kansas City and the office was Dr. Durrie.
` Pasquali had to do with the use of
`brimonidine for LASIK. And I believe it's not
`clear. And it may have -- it said radial
`keratotomy but it had to do with LASIK, that
`particular study.
` Q. Anything else?
` A. No.
` Q. Okay. Could you turn to the next
`page, 67?
` A. I'm sorry. What -- what page?
` Q. Page 67. At the top you'll see
`Exhibit A.
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Eye Therapies Exhibit 2162, 5 of 60
`Slayback v. Eye Therapies - IPR2022-00142
`
`

`

`Sher, Neal
`
`Case IPR2022-00142
`
`18
`
` A. Yes.
` Q. And is Exhibit A a copy of your
`current CV?
` A. The -- it is but the address has
`changed since I moved here in April.
` Q. And Exhibit A lists all your relevant
`professional experience; is that correct?
` A. Yes.
` Q. Other than the address that you
`mentioned is now different, are there any other
`updates to your CV that you would like to add?
` A. Not that I -- I noted. I think it's
`pretty -- pretty complete.
` Q. Thank you.
` Would you now flip to page 97?
`You'll see Exhibit B at the top.
` A. Yes.
` Q. And does Exhibit B contain the list
`of materials that you've considered in putting
`together your declarations in these two IPRs?
` A. Yes.
` Q. Did you review any documents that are
`not listed in Exhibit B in preparation of your
`declarations in these IPRs?
` MS. CIPRIANO: Objection to form.
`
`19
`
` THE WITNESS: I've practiced
` ophthalmology for 40 years and I think I've
` been a physician since 1971. So there are
` numerous things that I've read and know
` about and heard that would go into my
` overall knowledge on this matter. And I --
` and I, you know, they're not listed
` specifically here. So in addition -- those
` would be in addition.
`BY MR. DINER:
` Q. Who provided the documents listed in
`Exhibit B of your '742 declaration?
` A. Mr. Weinstein contributed them.
` Q. Anyone else?
` A. No.
` Q. Did you contribute any documents on
`your own to what we now see as Exhibit B?
` A. I believe I brought up the article by
`Murphy on "How Red is a" -- "How Red is a White
`Eye?" And the rest were provided.
` I was familiar with some. But in
`terms of providing these and sent to me as PDFs,
`Mr. Weinstein did.
` Q. So at least what you remember sitting
`here today is that you probably provided the
`
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`August 10, 2022
`6 (Pages 18 to 21)
`20
`Murphy reference and, as you recall, the rest
`were likely submitted or provided to you by
`Mr. Weinstein; is that fair?
` MS. CIPRIANO: Objection to form.
` THE WITNESS: In general, yes.
`BY MR. DINER:
` Q. Okay. You can temporarily put that
`aside. We'll just go through the other
`declaration just so it's of record.
` (Sher Deposition Exhibit 2 was
` marked for identification.)
`BY MR. DINER:
` Q. Okay. The court reporter has just
`handed you Sher Exhibit No. 2.
` Do you recognize this as the
`declaration you submitted in the IPR dealing
`with the U.S. Patent 9,259,425?
` A. Yes.
` Q. Okay. So as before, we'll call this
`the '425 declaration if you're okay --
` A. Sure. Sure.
` Q. Okay. Let's quickly go through this
`one as well.
` I believe if you turn to page 60.
` A. Six zero?
`
`21
`
` Q. Six zero, yes. Sorry about that.
` The signature on page 60, does that
`belong to you?
` A. Yes.
` Q. And did you explain how you prepared
`the '425 declaration?
` A. The answer would be the same as the
`'742 declaration.
` Q. Are there any corrections that you
`would like to make to the '425 declaration?
` A. I'd have to -- I just want to look
`through the last pages and just see. Again, it
`had to do with that Pasquali and Durrie
`reference. And I don't think that was in here.
`So the answer's no.
` Q. And just to be clear on the comments
`you made with regard to Pasquali, were you
`saying that in the '742 declaration that you --
`when you referenced Pasquali, you referenced it
`as talking about radial keratotomy instead of
`LASIK; is that correct?
` A. Yes.
` Q. Okay. Can you turn next in Sher
`Exhibit 2 to page 90?
` And you see Exhibit B there on
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Eye Therapies Exhibit 2162, 6 of 60
`Slayback v. Eye Therapies - IPR2022-00142
`
`

`

`Sher, Neal
`
`Case IPR2022-00142
`
`22
`
`page 90?
` A. Yes, sir.
` Q. And the documents that are listed
`there are the materials that you would have
`considered in putting together your '425
`declaration?
` A. That's correct.
` Q. And this is a complete list of
`materials that you considered in that regard?
` MS. CIPRIANO: Objection to form.
` THE WITNESS: The answer's the same
` as what I considered for the '742. And we
` did refer to Dr. Pasquali's article in
` Exhibit 1025. And, again, it's LASIK.
`BY MR. DINER:
` Q. Okay. And the documents that you
`would have provided in putting together the '425
`declaration would have been the Murphy document
`as well?
` A. Yes. It was a pretty complete set of
`articles sent to me before preparation.
` Q. And the rest of the documents cited
`in here to the best of your recollection would
`have been provided by Mr. Weinstein
`(pronunciation); is that fair?
`
`23
`
` A. By Mr. Weinstein, yes.
` Q. Weinstein. Sorry.
` Can you go back to Sher Exhibit
`No. 1, please?
` Okay. Let's go to page 67, your CV.
`Can you just take a look at pages 67 to 69 and I
`will ask you the question while you're looking
`at that.
` Do pages 67 to -- 67 to 69 of your
`declaration, pages 1 to 3 of your CV, describe
`your professional positions?
` A. Yes.
` Q. And other than those positions listed
`on page 1 --
` A. Of my CV we're talking about?
` Q. Yeah, yeah.
` -- have you had any other
`professional positions since 1 through 3?
` A. Could you be more specific? I --
`I've listed them. Is there -- I'm not sure of
`the question.
` Q. Sure. No problem.
` Other than what you see listed here
`on the first few pages of your CV up to where
`you start talking about articles, did you have
`
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`August 10, 2022
`7 (Pages 22 to 25)
`24
`any other professional positions other than what
`was listed there?
` A. No, I've been in practice from Eye
`Care Associates for the length of my clinical
`career. And I've had faculty positions for most
`of that at the University of Minnesota Medical
`School. And I've had staff appointments at the
`NIH and the Bureau of Biologics of the FDA.
` In terms of other positions, I'm not
`quite sure. I might be on a panel or a
`committee or things. I'm not sure if you're
`referring to that.
` Q. So in your CV in the '742 declaration
`at pages 74 through about 81, you list the
`number of different publications.
` And do any of these publications deal
`with the -- the drug that you mentioned earlier,
`brimonidine?
` A. Not directly, no.
` Q. Do they deal with brimonidine
`indirectly as far as you know?
` A. There may have been some early
`articles on red eye where I -- they were
`probably written before brimonidine in the early
`'90s. So I'd say no.
`
`25
`
` Q. And do any of these publications,
`abstracts, articles, textbooks, et cetera, do
`they concern the product called naphazoline?
` A. There were some articles. If I could
`have a minute to look in -- for some -- articles
`aimed at family doctors and primary care doctors
`about red eye.
` One of them is Aquavella, Eiferman,
`Sher, on page 75, "Red Eye: What's Dangerous?
`What's Not?" and some related articles, "Is Your
`Red Eye Rx Up to Date?" And that would probably
`include articles on alpha-1 -- on
`vasoconstrictors, naphazoline compounds such as
`Naphcon, or some of these ones you've mentioned,
`yes.
` Q. So going back to brimonidine, is that
`a product or a drug that you've worked with in
`the past?
` MS. CIPRIANO: Objection to form.
` THE WITNESS: I've used brimonidine
` in several forms throughout my clinical
` practice.
`BY MR. DINER:
` Q. How have you used it?
` A. I've used it for the treatment of
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Eye Therapies Exhibit 2162, 7 of 60
`Slayback v. Eye Therapies - IPR2022-00142
`
`

`

`Sher, Neal
`
`Case IPR2022-00142
`
`August 10, 2022
`8 (Pages 26 to 29)
`28
`
`26
`
`glaucoma.
` Q. What else?
` A. And I have used it at times to reduce
`hemorrhage, subconjunctival bleeding tendencies,
`in LASIK.
` Q. Have you done any research on
`brimonidine?
` A. No.
` Q. You don't recall if you've written
`any articles or publications on brimonidine, the
`drug itself?
` A. I did not write any publications.
` Q. Okay. So is it fair to say that your
`use with brimonidine is limited to administering
`it in a clinical setting?
` MS. CIPRIANO: Objection to form.
` THE WITNESS: I have used it in a
` clinical setting, correct.
`BY MR. DINER:
` Q. Have you used it in any way outside
`of the clinical setting?
` MS. CIPRIANO: Objection. Form.
` THE WITNESS: I don't -- I don't
` understand the question.
`
`27
`
`BY MR. DINER:
` Q. Yeah. So you haven't done any
`research work on brimonidine, right?
` A. I said I did not, correct.
` Q. Okay. And you don't recall writing
`any articles or publications on brimonidine,
`correct?
` A. I did not.
` Q. But you have used it clinically?
` A. Yes.
` Q. So my question is: Other than using
`it clinically, have you used it in any way or
`research done on it in any way outside of the
`clinical area?
` A. No.
` MS. CIPRIANO: Objection to form.
`BY MR. DINER:
` Q. How about naphazoline, have you done
`any research work on naphazoline?
` A. No.
` MS. CIPRIANO: Objection to form.
` THE WITNESS: No.
`BY MR. DINER:
` Q. Have you used it clinically?
` A. Yes.
`
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` Q. Other than using it clinically, have
`you used it in any other way?
` A. No.
` Q. Are you familiar with the compound
`called tetrahydrozoline?
` A. Yes.
` Q. Have you used tetrahydrozoline
`clinically?
` A. Yes.
` Q. Have you done any research work with
`respect to tetrahydrozoline?
` MS. CIPRIANO: Objection to form.
` THE WITNESS: No.
`BY MR. DINER:
` Q. You understand what I mean by
`"research work," right?
` A. Well, used, I would take that as
`using it outside of recommending it to patients
`in a clinical setting, did I use it on rabbits
`or mice or in a laboratory. And the answer's
`no.
` Q. Have you done any clinical trial work
`with tetrahydrozoline?
` A. No.
` Q. Same question with respect to
`
`29
`
`brimonidine?
` A. No.
` Q. And same question with respect to
`naphazoline?
` A. No.
` Q. Are you familiar with the compound
`oxymetazoline?
` A. I've -- I'm familiar with it.
` Q. Have you ever used it clinically?
` A. It's generally not -- I may have used
`it on occasion. It's not one that was in my
`therapeutic arm of material.
` Q. And why was that?
` A. I don't recall.
` Q. Do you recall if oxymetazoline has
`any properties that are disadvantageous for use
`by patients?
` MR. WEINSTEIN: I'm going to just --
` I didn't hear the question. I don't know
` what we're talking about.
`BY MR. DINER:
` Q. I'll restate the question.
` Do you recall whether oxymetazoline
`has any properties that you would have
`considered disadvantageous for patients?
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Eye Therapies Exhibit 2162, 8 of 60
`Slayback v. Eye Therapies - IPR2022-00142
`
`

`

`Sher, Neal
`
`Case IPR2022-00142
`
`August 10, 2022
`9 (Pages 30 to 33)
`32
`
`30
`
` A. I don't recall.
` Q. I'm going to try -- if I've asked you
`these questions, if I have, I apologize. And I
`just ask your indulgence because I'll ask them
`again then.
` But have you done any research work
`on oxymetazoline?
` A. No, sir.
` MS. CIPRIANO: Objection to form.
` THE WITNESS: No.
`BY MR. DINER:
` Q. And you haven't written any
`publications or articles on the drug
`oxymetazoline?
` A. No.
` Q. Have you ever lectured on
`brimonidine?
` A. No.
` Q. Is it fair to say that you also have
`not lectured on naphazoline?
` A. That's correct.
` Q. And is it also fair to say you have
`not lectured on tetrahydrozoline?
` A. Yes.
` Q. Nor have you lectured on
`
`31
`
`oxymetazoline?
` A. That's correct.
` Q. Do you have any patents on --
`covering the use of brimonidine in any way?
` A. No.
` Q. Do you have any patents covering the
`use of naphazoline?
` A. No.
` Q. And no patents covering the use of
`tetrahydrozoline?
` A. No, I do not have patents concerning
`-- concerning that drug.
` Q. Nor do you have any patents
`concerning oxymetazoline, correct?
` A. That's correct.
` Q. So in connection with these
`proceedings, in what areas do you consider
`yourself to be an expert?
` MS. CIPRIANO: Objection to form.
` THE WITNESS: I have practiced
` ophthalmology for 40 years. I have
` additional training in pediatrics. I've
` spent three years at the National
` Institutes of Health doing vaccine
` research, immunotherapy work, and some eye
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` immunology work.
` I've worked in the field of -- I
` reviewed FDA applications as part of being
` assigned to the FDA during those three
` years.
` I've run numerous clinical
` trials and participated in other clinical
` trials on a number of drugs.
` I have performed close to 10,000
` refractive surgeries, including LASIK and
` PRK.
` I have researched the use of
` certain medicines and pain -- for pain
` control after eye surgery and own a patent
` related to that.
`BY MR. DINER:
` Q. Is that patent related -- strike
`that.
` Is that patent that you just
`referenced identified in your CV?
` A. It should be.
` Q. Can you help me find where it may be?
` A. It's on page 71 of the '742
`declaration.
` Q. Is it Patent No. 6,117,907?
`
`33
`
` A. That's correct.
` Q. Do you recall if -- strike that.
` Can I refer to this as the '907
`patent?
` A. Sure.
` Q. Do you recall if the '907 patent
`dealt in any way with the use of brimonidine to
`treat ocular pain?
` MS. CIPRIANO: Objection. Form.
` THE WITNESS: It did not.
`BY MR. DINER:
` Q. What were the treatments, if you
`recall, in that patent for treating ocular pain?
` A. The patent discussed or described the
`use of diclofenac, a nonsteroidal anti-inflammatory
`drop, combined with some other methods,
`including soft contact lenses, steroid, and
`antibiotic as a method of treating pain post
`corneal laser surgery.
` Q. When you refer to corneal laser
`surgery, is that LASIK?
` A. It can be, yes, or PRK.
` Q. And PRK is radial keratotomy?
` A. No.
` Q. No.
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Eye Therapies Exhibit 2162, 9 of 60
`Slayback v. Eye Therapies - IPR2022-00142
`
`

`

`Sher, Neal
`
`Case IPR2022-00142
`
`34
`
` What does the PRK means?
` A. Stands for, Mr. Diner,
`photorefractive keratectomy. It preceded LASIK
`and works on the same principle using the same
`laser and the principle of flattening a cornea
`to get rid of nearsightedness or steepening it
`to treat something else.
` Q. Is it fair to say that it came after
`radial keratectomy but before LASIK surgery?
` A. Yes.
` Q. So you mentioned that the '907 patent
`dealt with diclofenac and you said diclofenac
`was an NSAID; is that correct?
` A. Yes.
` Q. What other analgesics were used
`and/or discussed in that patent for treating
`ocular pain?
` MS. CIPRIANO: Objection to form.
` THE WITNESS: I'd have to look
` through the patent. And I don't recall.
` In the description we probably mention
` some.
`BY MR. DINER:
` Q. Do you recall if you used any
`anesthetics for treating pain, ocular pain that
`
`35
`
`is?
` MS. CIPRIANO: Objection to form.
` THE WITNESS: I don't recall.
`BY MR. DINER:
` Q. A few moments ago when answering the
`question about what areas you consider yourself
`to be an expert in, you mentioned clinical
`trials.
` Do you recall that?
` A. I said that, yes.
` Q. How, if at all, does your clinical
`trial work prepare you to be an expert in this
`case?
` MS. CIPRIANO: Objection to form.
` THE WITNESS: My clinical trial work
` gives me the experience that I have had
` running or participating in trials to
` understand the best I can methodology, how
` trials are run, how to get accur